Thursday, August 29, 2013

Dietary Supplement Warning Letter Immersion Center - Letters Categorized by Type

If you're tracking FDA Warning Letters issued to dietary supplement companies, follow the link below:

NPI Warning Letter Immersion Center:

"This Warning Letter Immersion Center is a place to find the latest information on warning letters sent to dietary supplement and related companies. Included is a table of all the known warning letters to date, including a link to the full text of each letter on FDA website."

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Tuesday, August 20, 2013

FDA - 70% of Supplement Companies Violate Rules

FDA official: 70% of supplement companies violate agency rules:

"About 70 percent of the nation's supplement companies have run afoul of the U.S. Food and Drug Administration's manufacturing regulations over the past five years, according to a top agency official.

Consumers are put at risk by poorly measured ingredients, uncleaned manufacturing equipment, pesticides in herbal products, supplements contaminated with illegal prescription medications -- even bacteria in pediatric vitamins, recall notices and agency inspection records have shown."

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Friday, August 16, 2013

Medical Foods > FDA Draft Guidance for Industry: FAQs 2nd Ed

Medical Foods > Draft Guidance for Industry: Frequently Asked Questions About Medical Foods; Second Edition:

"The responses to these FAQs address common questions about the definition of and regulations for medical foods. This guidance is a second edition of the May 2007 guidance titled “Guidance for Industry: Frequently Asked Questions About Medical Foods.” This guidance provides responses to additional questions regarding the definition, labeling, and availability of medical foods and updates to some of the existing responses; new questions and answers and amended responses are identified by the date they were added to the guidance."

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Tuesday, August 13, 2013

8 Key cGMP Areas FDA Inspectors Focus On | FDAzilla Blog

8 Key cGMP Areas FDA Inspectors Seem to Focus On | FDAzilla Blog:

"As you prepare for your next FDA inspections, bear in mind some of the key focus areas, which were high priorities for FDA inspectors in the last few years—all driven by patient safety concerns, according to a top pharma executive:" . . .

Follow the link above to the list of 8 key areas.

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Monday, August 12, 2013

2014 Yellow Book Home | Travelers' Health | CDC

2014 Yellow Book Home | Travelers' Health | CDC:

"Explore Travel Health with the new 2014 Yellow Book!

CDC Health Information for International Travel (commonly called the Yellow Book) is published every two years by CDC as a reference for those who advise international travelers about health risks. The Yellow Book is written primarily for health professionals, although others will find it useful."

Follow this link to the CDC Yellow Book (online)

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Friday, August 2, 2013

Gluten-Free Labeling of Foods - FDA Final Rule

Allergens > Gluten-Free Labeling of Foods:

"On August 2, 2013, FDA issued a final rule defining “gluten-free” for food labeling, which will help consumers, especially those living with celiac disease, be confident that items labeled “gluten-free” meet a defined standard for gluten content."

Follow this link to Food Labeling; Gluten-Free Labeling of Foods - FDA Final Rule

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6 Questions For A Veteran FDA Investigator | FDAzilla Blog

6 Questions For A Veteran FDA Investigator | FDAzilla Blog:

"Today we have the privilege of interviewing former FDA investigator, Luis Chavarria. After 30 years of conducting, managing, and supervising inspections, his insights are worthy of heavy consideration."

You might also be interested in this course:
Surviving an FDA Inspection

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